Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma
Completed · Phase 2 · Has a placebo group
Conditions studied: Asthma
In brief
The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.
Key facts
- Study ID
- NCT01634113
- Run by
- Boehringer Ingelheim
- People needed
- 102
- Starts
- 2012-07-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-06-23
Who can join
Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients' parents (or legal guardians) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial. Where appropriate, participants should assent to enroll in the study.
- Male or female patients between 1 and 5 years of age.
- By a physician documented (at least 6 month) history of persistent asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath. (persistent = need for inhalation corticosteroid maintenance therapy to control asthma symptoms)
- For patients aged 5 years and capable of performing technically acceptable Pulmonary Function tests (PFTs): documented impaired lung function (i.e. pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is smaller or equal to 90% of predicted normal).
- All patients must have been on maintenance treatment with an inhaled corticosteroid at stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before Visit 1.
- All patients must be symptomatic (partly controlled) as defined by the Global Initiative for Asthma (GINA) guideline for children aged 5 years and younger in the week prior to Visit 1 (screening) and in the week prior to randomisation (Visit 2).
- Further inclusion criteria apply.
You may not qualify if…
- Patients with a significant disease other than asthma.
- Patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1.
- Patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year.
- Patients with any unstable or life-threatening cardiac arrhythmia, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation) or a change in drug therapy within the past year.
- Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy.
- Patients with clinically significant lung diseases other than asthma.
- Alternative causes (other causes than asthma) that can lead to respiratory symptoms of wheeze, cough and shortness of breath.
- Patients with known active tuberculosis.
- Patients who have undergone thoracotomy with pulmonary resection.
- Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
- Further exclusion criteria apply.
Where it is running
- 205.443.12003 Boehringer Ingelheim Investigational Site — Columbia, Missouri, United States
- 205.443.12005 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
- 205.443.12006 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
- 205.443.12004 Boehringer Ingelheim Investigational Site — Summerville, South Carolina, United States
- 205.443.01004 Boehringer Ingelheim Investigational Site — Antwerp, Belgium
- 205.443.01002 Boehringer Ingelheim Investigational Site — Brussels, Belgium
- 205.443.01001 Boehringer Ingelheim Investigational Site — Edegem, Belgium
- 205.443.02002 Boehringer Ingelheim Investigational Site — Helsinki, Finland
- 205.443.02003 Boehringer Ingelheim Investigational Site — Turku, Finland
- 205.443.03003 Boehringer Ingelheim Investigational Site — Berlin, Germany
- 205.443.03001 Boehringer Ingelheim Investigational Site — Bochum, Germany
- 205.443.03002 Boehringer Ingelheim Investigational Site — Ettenheim, Germany
- 205.443.03010 Boehringer Ingelheim Investigational Site — Frankfurt, Germany
- 205.443.05001 Boehringer Ingelheim Investigational Site — Balvi, Latvia
- 205.443.05003 Boehringer Ingelheim Investigational Site — Rēzekne, Latvia
- 205.443.05002 Boehringer Ingelheim Investigational Site — Riga, Latvia
- 205.443.06002 Boehringer Ingelheim Investigational Site — Vilnius, Lithuania
- 205.443.06003 Boehringer Ingelheim Investigational Site — Vilnius, Lithuania
- 205.443.10002 Boehringer Ingelheim Investigational Site — Kelantan, Malaysia
- 205.443.10001 Boehringer Ingelheim Investigational Site — Kuala Lumpur, Malaysia
- 205.443.10003 Boehringer Ingelheim Investigational Site — Kuala Pahang, Malaysia
- 205.443.04003 Boehringer Ingelheim Investigational Site — Breda, Netherlands
- 205.443.04001 Boehringer Ingelheim Investigational Site — Groningen, Netherlands
- 205.443.09001 Boehringer Ingelheim Investigational Site — Quezon City, Philippines
- 205.443.09002 Boehringer Ingelheim Investigational Site — Quezon City, Philippines
Full record on ClinicalTrials.gov
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